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EC number: 470-470-3 | CAS number: 9022-75-7
Table 2: mean final body weights and mean ovaries weights
Number of females
n = 10
Final mean body weight (g)
352.9 ± 27.34
351.8 ± 22.42
370.3 ± 26.07
345.0 ± 26.35
Number of pregnant females
n = 7
n = 8
n = 9
Ovaries mean weight (g)
0.21686 ± 0.027
0.20538 ± 0.036
0.16889 ± 0.027 **
0.17650 ± 0.024 *
Mean % body
0.05926 ± 0.009
0.05766 ± 0.013
0.04553 ± 0.010 *
0.04989 ± 0.005
Mean ± SD; */**): Dunnett's test based on pooled variances at 5% (*) or 1% (**) level
In a GLP study conducted according to OECD guideline 421, Chimexane NV was administered daily by oral gavage to male and female Sprague-Dawley rats (10/sex/dose) at dose-levels of 50, 150 or 600 mg/kg bw/day for 2 weeks before mating, during mating, gestation and until day 4 post-partum for the females, and after the majority of the females per group had delivered, for the males. A control group received the vehicle (purified water) under the same experimental conditions.
During the dosing period, each F0 animal was observed twice daily for mortality and once daily for clinical signs. Body weight was recorded once before group allocation, on the first day of treatment and then about once a week until sacrifice. Food consumption was recorded about once a week, over a 7-day period, from the first day of treatment until sacrifice (except during the mating period). Animals were paired for a maximum of 14 days and the estrous cycle stage was recorded each morning until mating occurred. All F0 females of all groups were allowed to deliver normally and to rear their progeny until day 5 p.p.. Gestation and litter parameters were recorded and during the lactation period each pup was observed daily for survival and clinical signs. Pup body weight was recorded on days 1 and 5 p.p.. A macroscopic post-mortem examination was performed on all F0 parent animals and on all pups. All macroscopic lesions were sampled and preserved. Testes, epididymides, prostate and seminal vesicles from all F0 males and ovaries from all F0 females which delivered and were sacrificed on day 5 p.p. were weighed. Testes, epididymides, ovaries and any macroscopic lesions from F0 high-dose and control parent animals were microscopically examined.
The test item elicited effects at 600 mg/kg bw/day including transient reduced body weight gain and food consumption, particularly in the males, and excessive salivation, loud breathing and half-closed eyes in both sexes. There were no effects on mating, fertility, gestation or delivery and survival of the pups was not affected during the first days of lactation. There were no treatment-related macroscopic or microscopic findings. Similar clinical signs (excessive salivation) were observed in animals treated at 150 mg/kg bw/day but at a much lower incidence. These signs were considered not to be adverse. No other effects were observed. No treatment-related effects were observed at 50 mg/kg bw/day.
Under the experimental conditions of this study, it was considered that the No Observed Adverse Effect Level (NOAEL) for systemic toxicity is 150 mg/kg bw/day, the No Observed Effect Level (NOEL) for mating and fertility is 600 mg/kg bw/day and the NOAEL for developmental toxicity is 600 mg/kg bw/day.
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